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Role of Prednisolone (drug) in Steroid (drug) Responsive Severe Alcoholic Hepatitis(liver disease).

Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis. - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061345
Enrollment
150
Registered
2024-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K758- Other specified inflammatory liverdiseases

Interventions

Intervention1: Extended Steroid Therapy: 10mg of prednisolone plus standard medical therapy for 60 days. Standard Medical Treatment - IV Albumin, Diuretics, Multi vitamins as per clinicians decision C

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Persistence of mDF > 32 at day 28 of steroids

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Uncontrolled sugars 3. No consent

Design outcomes

Primary

MeasureTime frame
To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMTTimepoint: 90 days

Secondary

MeasureTime frame
90 day readmission ratesTimepoint: 90 days;New onset infections, diabetesTimepoint: 90 days;To assess the effect of extended low dose steroids in steroid responsive SAH on CTP, MELD-Na, DFTimepoint: 90 days;To assess the effect of extended low dose steroids in steroid responsive SAH on transplant free survivalTimepoint: 90 days

Countries

India

Contacts

Public ContactDr Shasthry S M

Institute of Liver and Biliary Sciences

shasthry@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026